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A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML

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Trial Profile

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jan 2024

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At a glance

  • Drugs Gilteritinib (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms MORPHO
  • Sponsors Astellas Pharma

    • Most Recent Events

    • 12 Dec 2023 Results of post-hoc analysis assessing the impact on relapse-free survival of different levels of FLT3-ITD variant allele frequency pre-randomization (immediately before or after HCT but prior to randomization to gilteritinib or placebo), the impact of the presence of multiple mutations detected as MRD pre-HCT and the eradication of FLT3-ITD clones detected post-HCT during follow up on gilteritinib or placebo, presented at the 65th American Society of Hematology Annual Meeting and Exposition.
    • 27 Jul 2023 Status changed from active, no longer recruiting to completed.
    • 15 Jun 2023 Results presented at the 28th Congress of the European Haematology Association
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